Assays

Dec. 23, 2024

Extend the power of HPV testing BD Onclarity HPV Assay offers extended genotyping to identify high-risk HPV types beyond 16, 18, and 45 and is approved for self-collection in ...

Sponsored Content

Assays

Value of a Chromatogram in Hemoglobin A1C Testing

Nov. 13, 2024

PIQRAY® is a registered trademark of Novartis AG. VECTIBIX® is a registered trademark of Immunex Corporation. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST® is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA® is a registered trademark of Merck. LENVIMA® (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

Assays

Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic (CDx) test

LABline

Nov. 8, 2024

yourgene_cystic_fibrosis_base_assay_ivdr

Assays

Yourgene Health Cystic Fibrosis Base assay receives IVDR accreditation

LABline

Oct. 18, 2024

Sponsored Content

Video

Accessible and Accurate Testing Solutions from Home to Lab by Sekisui Diagnostics

Sept. 20, 2024

Assays

QIAGEN expands QIAcuity digital PCR offering with over new 100 assays via GeneGlobe platform

LABline

Sept. 19, 2024

Sponsored Content

Video

CLSI’s Focused on Preparing Labs for Change

Sept. 11, 2024

Clinical and Laboratory Standards Institute (CLSI) CEO Barb Jones shares how the global nonprofit’s standards, training and educational offerings prepare labs to meet the...

Assays

VITROS syphilis assay now available on VITROS 3600 immunodiagnostic system, VITROS 5600 and VITROS XT 7600 integrated systems in the U.S.

LABline

Aug. 30, 2024

QuidelOrtho receives FDA 510(k) clearance for its VITROS syphilis assay.

Sponsored Content

Video

Flexible Syndromic Solutions for Respiratory Diagnostics 

Aug. 30, 2024

Michelle Tabb and Giulia Amicarelli of Diasorin discuss the current challenges for respiratory testing and how customizable syndromic testing is contributing to diagnostic stewardship...

Assays

Bio-Rad launches new Specialty Immunoassay Plus controls

LABline

Aug. 23, 2024

Next generation of independent specialty IA quality controls features procalcitonin in liquid format.

Assays

Thermo Fisher Scientific announces extended 510k Clearance of Freelite Assays for evaluation of MGUS, a precursor to multiple myeloma

LABline

July 30, 2024

Thermo Fisher update.

Assays

Diasorin receives FDA de-Novo grant for the Simplexa C. auris Direct assay on the LIAISON MDX instrument

LABline

July 19, 2024

Simplexa C. auris Direct is a is a real-time polymerase chain reaction assay run on the LIAISON MDX instrument for the direct in vitro qualitative detection of Candida auris DNA...

Assays

Siemens Healthineers offers new way to detect a broken heart: NT proBNPII assay now part of Atellica cardiac testing menu

LABline

June 28, 2024

NT-proBNP is a cardiac biomarker that helps diagnose heart failure.

Assays

Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) — a key marker for hereditary cardiovascular risk

LABline

May 23, 2024

The test has been developed in collaboration with Amgen.

Assays

OGT launches new SureSeq Myeloid Fusion Panel to help drive advances in myeloid cancer research

LABline

May 2, 2024

A single streamlined NGS process.

Assays

Roche granted FDA Breakthrough Device Designation for pTau217 blood test to support earlier Alzheimer's disease diagnosis

LABline

April 12, 2024

Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis.

Assays

Assays

New reproductive assay from Siemens Healthineers provides critical information to guide in vitro fertilization decisions

LABline

March 14, 2024

Assays

Complications and diagnosis of pre-eclampsia

Jason Armstrong

Feb. 26, 2024

Assays

QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems

LABline

Jan. 8, 2024

Assays

Product Focus - Assays

MLO Staff

Dec. 18, 2023

Assays

Carolina Liquid Chemistries now offers K-ASSAY CLIA moderate complexity Microalbumin reagent for use on the Medica EasyRA benchtop clinical chemistry analyzer

LABline

Dec. 1, 2023

Assays

Association for Molecular Pathology publishes best practice recommendations for liquid biopsy assay validations

LABline

Oct. 13, 2023

Assays

Thermo Fisher announces FDA-clearance of automated assay to assess tumor progression in neuroendocrine cancer patients

LABline

Sept. 28, 2023

Product Focus- Assays/Controls

Value of a Chromatogram in Hemoglobin A1C Testing

Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic (CDx) test

Yourgene Health Cystic Fibrosis Base assay receives IVDR accreditation

Accessible and Accurate Testing Solutions from Home to Lab by Sekisui Diagnostics

QIAGEN expands QIAcuity digital PCR offering with over new 100 assays via GeneGlobe platform

CLSI’s Focused on Preparing Labs for Change

VITROS syphilis assay now available on VITROS 3600 immunodiagnostic system, VITROS 5600 and VITROS XT 7600 integrated systems in the U.S.

Flexible Syndromic Solutions for Respiratory Diagnostics

Bio-Rad launches new Specialty Immunoassay Plus controls

Thermo Fisher Scientific announces extended 510k Clearance of Freelite Assays for evaluation of MGUS, a precursor to multiple myeloma

Diasorin receives FDA de-Novo grant for the Simplexa C. auris Direct assay on the LIAISON MDX instrument

Siemens Healthineers offers new way to detect a broken heart: NT proBNPII assay now part of Atellica cardiac testing menu

Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) — a key marker for hereditary cardiovascular risk

OGT launches new SureSeq Myeloid Fusion Panel to help drive advances in myeloid cancer research

Roche granted FDA Breakthrough Device Designation for pTau217 blood test to support earlier Alzheimer's disease diagnosis

Assays

New reproductive assay from Siemens Healthineers provides critical information to guide in vitro fertilization decisions

Complications and diagnosis of pre-eclampsia

QIAGEN receives FDA clearance of NeuMoDx CT/NG Assay for use on both NeuMoDx 96 and 288 Molecular Systems

Carolina Liquid Chemistries now offers K-ASSAY CLIA moderate complexity Microalbumin reagent for use on the Medica EasyRA benchtop clinical chemistry analyzer

Association for Molecular Pathology publishes best practice recommendations for liquid biopsy assay validations

Thermo Fisher announces FDA-clearance of automated assay to assess tumor progression in neuroendocrine cancer patients

Flexible Syndromic Solutions for Respiratory Diagnostics 